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Breast CancerPhase 2POP-ELANCT07159451

A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer

A Phase 2 study testing Elacestrant and Leuprorelin in people with Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A prospective randomized trial designed to evaluate the mean decrease in Ki67 after 4 weeks of elacestrant monotherapy and in combination with leuprorelin in patients with early-stage HR+ BC. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Elacestrant and Leuprorelin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteFrance
Study dates
6 Oct 2025to 29 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Each patient must meet all of the following inclusion criteria to be randomized in the study:
  • Aged 18 or more.
  • Signed Informed Consent Form prior to any study-specific procedure. Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures.
  • Patients must be affiliated to a Social Security System (or equivalent).
  • Premenopausal women ensured by checking if the women were still having regular periods over the last 6 months without any hormonal treatment or hormonal contraception or if they were irregular, FSH and estradiol levels must fall within the premenopausal range according to local laboratory definition.
  • Histologically confirmed invasive breast carcinoma, confirmed by the local pathologist, ER-positive tumor cells ≥ 10% ER staining BC and HER2- according to ASCO criteria in immunohistochemistry (IHC) and/or genomic analysis (HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and in situ hybridization non-amplified]), Ki67 index by local analysis of ≥ 10% and ≤ 30% on untreated tumor tissue.
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  • Clinical stage I or II according to the eight edition of the American Joint Committee on Cancer, eligible for primary breast surgery.
  • Note: Multifocal and multicentric tumors are permitted if they are considered clinical stage I or II according to Eight Edition of the AJCC. Biopsy of all lesions is not necessary and is left at the description of the investigator, but endocrine therapy response must be evaluated on the same tumor
  • Available pre-treatment tru-cut biopsy evaluable.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 14 days prior to the date of randomization.
  • Women of childbearing potential have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication.
  • Demonstrate adequate organ function within 7 days of inclusion :
  • Absolute neutrophil count ≥ 1.0 x 109/L
  • Platelet count ≥ 75 x 109/L
  • Hemoglobin ≥ 9.0 g/dL
  • Estimated glomerular filtration rate ≥30 mL/min/1.73 m² or creatinine clearance calculated by Cockcroft-Gault equation ≥ 30 mL/min Creatinine clearance ≥ 30 mL/min for subject with creatinine levels > 1.5 x institutional upper limit of normal (ULN).
  • Alanine aminotransferase (ALT) ≤ 2.5x upper limit of normal (ULN).
  • Aspartate aminotransferase (AST) ≤ 3x ULN.
  • Total bilirubin ≤ ULN or total bilirubin ≤ 1.5x ULN with direct bilirubin ≤ ULN of the laboratory in subjects with documented Gilbert's Syndrome.
  • Potassium, sodium, calcium (corrected for albumin), magnesium, and phosphorus CTCAE v5.0 Grade ≤ 1. If Screening assessments are abnormal, chemistry assessments may be repeated up to 2 times; subjects may receive appropriate supplementation or treatment (eg, for hypercalcemia) prior to re-assessment.
  • International normalized ratio (INR) ≤ 1.5; subjects who are receiving anticoagulation treatment which is monitored by international normalized ratio (INR) (eg, warfarin) may be allowed to participate if they have a stable INR (ie, within therapeutic range) for at least 28 days prior to the first dose of study drug, in the absence of any exclusionary medical conditions, and provided that elacestrant would be appropriate therapy for the subject.
  • Women of childbearing potential must agree to use protocol-specified method(s) of contraception during trial treatments and for at least 120 days after the last dose of trial treatments. Highly effective contraception methods include:
  • Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
  • Placement of a non-hormonal intrauterine device.

Who cannot join

  • Patients who meet any of the following exclusion criteria will not be eligible for this study.
  • Patients non-candidate for upfront breast surgery or candidate for neoadjuvant chemotherapy.
  • Any systemic therapy (e.g, chemotherapy, targeted therapy, immune-therapy) or radiotherapy for current BC before study entry.
  • Prior treatment with LHRH-agonists over the last 6 months prior to the ICF signature.
  • Any active treatment for any cancer disease.
  • Any of the following within 6 months before enrollment:
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  • Myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE v5.0 Grade ≥2,
  • Prolonged QTcF ≥ Grade 2 (ie, > 480 msec), uncontrolled atrial fibrillation of any grade, coronary/peripheral artery bypass graft, heart failure ≥ Class II as defined by the New York Heart Association guidelines,
  • Cerebrovascular accident including transient ischemic attack
  • Child-Pugh Score greater than Class A,
  • Has a known hypersensitivity (≥ Grade 3) to the components of the study therapy or its analogs.
  • Coagulopathy or any history of coagulopathy within the past 6 months, including history of deep vein thrombosis or pulmonary embolism. However, subjects with the following conditions will be allowed to participate:
  • Adequately treated catheter-related venous thrombosis occurring > 28 days prior to the first dose of study drug
  • Treatment with an anticoagulant, eg, warfarin or heparin, for a thrombotic event occurring > 6 months before enrollmentenrolment, or for an otherwise stable and allowed medical condition (eg, well controlled atrial fibrillation), provided dose and coagulation parameters (as defined by local standard of care) are stable for at least 28 days prior to the first dose of study drug and provided that an AI would be an appropriate therapy for the subject.
  • Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications such as: uncontrolled nausea or vomiting (ie, CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction/motility disorder, malabsorption syndrome, or prior gastric bypass.
  • Unable or unwilling to avoid prescription medications, over-the-counter medications, dietary/herbal supplements (eg, St. John's wort), and/or foods (eg, grapefruit, pomelos, star fruit, Seville oranges and their juices) that are moderate/strong inhibitors or inducers of CYP3A4 activity. Participation will be allowed if the medication, supplements, and/or foods are discontinued for at least 5 half-lives or 14 days (whichever is longer) prior to study entry and for the duration of the study.
  • Pregnancy or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes.
  • Any concurrent severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with compliance with study procedures or the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
  • Person deprived of their liberty or under protective custody or guardianship.
  • Psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol.
  • Patients unwilling to or unable (as assessed by the investigator) to comply with the protocol.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elie El Rassy, MD contact

+33 01 42 11 42 11

Elie.EL-RASSY@gustaveroussy.fr

Chloé Serhal, PhD contact

+33 01 42 11 42 11

Chloe.serhal@gustaveroussy.fr

France1 site, 1 recruiting

  • Gustave Roussy

    Villejuif

    Jean Zeghondy, MD, + 33 01 42 11 42 11, Jean.ZEGHONDY@gustaveroussy.fr

    Recruiting

Other trials in France

About this study

Official title: A Short-term Preoperative, Window-of-opportunity Study, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer

A prospective randomized trial designed to evaluate the mean decrease in Ki67 after 4 weeks of elacestrant monotherapy and in combination with leuprorelin in patients with early-stage HR+ BC. This preoperative study will enroll consecutive patients with early stage HR+ BC who are not candidates for neoadjuvant chemotherapy but are eligible for short-term preoperative treatment with elacestrant, with or without leuprorelin, followed by breast surgery. A total of three dedicated Formalin-fixed paraffin embedded (FFPE) samples (mandatory for all patients), along with two frozen biopsy (only for participants at Gustave Roussy), are planned to be collected at the time of inclusion from the biopsy sample and from the surgical specimen. Blood samples will also be collected throughout the study.

Conditions
Breast Cancer
Being tested
Elacestrant, Leuprorelin
Keywords
early-stage, HR+ breast cancer, breast cancer, premenopausal patients, stage I-II, ER+/HER2- breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElacestrantDrug

    Patients will receive elacestrant 345 mg/daily administered orally for 4 weeks.

  • LeuprorelinDrug

    Patients randomized in arm B will recieve Leuprorelin at Day 1 and Day 29

Study groups in NCT07159451
Study groupRoleWhat they receive
Experimental group AExperimentalPatients will receive elacestrant 345 mg/daily administered orally for 4 weeks.
Receives: Drug: Elacestrant
Experimental group BExperimentalPatients will receive elacestrant 345 mg/daily administered orally for 4 weeks with leuprorelin LP 3.75 mg intramuscular Day 1 and Day 29.
Receives: Drug: Elacestrant; Drug: Leuprorelin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine if 4 weeks of elacestrant monotherapy determines a non-inferior anti-proliferative effect, measured by Ki67, in comparison to elacestrant with leuprorelin in premenopausal patients with ER-positive/HER2- operable invasive BC.

    Measured: Surgery

Secondary outcomes (9)

  1. Complete cell cycle arrest (CCCA) measured by Ki67 <2.7%

    Measured: Surgery

  2. Objective Response Rate

    partial and complete response obtained as measured by MRI

    Measured: From baseline to day 29

  3. Rate of pathological of partial and complete response

    Measured: at surgery

  4. Levels of estradiol

    Measured: at baseline, Day 14, and Day 28 then postoperatively at 1 month

  5. Levels of follicle-stimulating hormone (FSH)

    Measured: at baseline, Day 14, and Day 28 then postoperatively at 1 month

  6. Levels of luteinizing hormone (LH)

    Measured: at baseline, Day 14, and Day 28 then postoperatively at 1 month

  7. Incidence of treatment-emergent AEs

    assessed by the national cancer institute (NCI) Common Terminology for Classification of Adverse Events (CTCAE) version 5.0,

    Measured: From enrollment until 28 days post surgery

  8. Duration of treatment-emergent AEs

    assessed by the national cancer institute (NCI) Common Terminology for Classification of Adverse Events (CTCAE) version 5.0,

    Measured: From enrollment until 28 days post surgery

  9. Severity of treatment-emergent

    AEs assessed by the national cancer institute (NCI) Common Terminology for Classification of Adverse Events (CTCAE) version 5.0

    Measured: From enrollment until 28 days post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2025
  2. Study start6 Oct 2025
  3. Primary completion29 Jan 2027 (estimated)
  4. Study completion29 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07159451
Sponsor's protocol ID
2024-520051-24-00
Other IDs
2025/4053
Acronym
POP-ELA
Status last verified
Nov 2025
First submitted
19 Aug 2025
Last updated
1 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elacestrant and Leuprorelin in people with Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elie El Rassy, MD (+33 01 42 11 42 11, Elie.EL-RASSY@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine if 4 weeks of elacestrant monotherapy determines a non-inferior anti-proliferative effect, measured by Ki67, in comparison to elacestrant with leuprorelin in premenopausal patients with ER-positive/HER2- operable invasive BC. (time frame: Surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07159451.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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